Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double‐blind placebo‐controlled clinical trial

Abstract

A randomized double‐blind placebo‐controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative changes that might not be reflected in performance measurements. We also judged range of motion, degree of spasticity, and muscle growth measured by CT. Fifty seven of 82 outpatients who were able to walk at least with a walker, completed all 12 months of treatment (hemiplegia n=25, diplegia n=32). There was no significant difference between active and placebo treatment in any of the tested groups, nor combined. Visual and subjective assessments favoured TES (ns), whereas objective indices showed the opposite trend. We conclude that TES in these patients did not have any significant clinical effect during the test period.

Does Threshold Nighttime Electrical Stimulation Benefit Children With Spina Bifida?: A Pilot Study

“…The intensity of our treatment program was similar to other TES studies that had reported 63% to 100% compliance for 6 to 9 months of treatment [1,2,[8][9][10]. Dali et al [2] found 13 of 82 patients left their study because they lost interest or found the treatment too inconvenient. Complying with an intensive treatment program may be a particular problem for the myelomeningocele population because the caregiver burden for them is already high.…”

“…Similarly, no change in motion was observed by Dali et al [2] in TES treatment in children with cerebral palsy. We also found no change in lower extremity sensation.…”

“…However, walking function, measured by the Progressive Ambulation Scale, improved in only one patient. Dali et al [2] also noted visual and subjective assessments that showed improvement with TES could not be borne out by objective measures.…”

“…Other authors report low rates of complications; most commonly were skin irritation from the electrodes or adhesives [2,8].…”

“…At 1 year postrhizotomy, those children who used TES had a statistically better outcome based on the Gross Motor Functional Measure, a validated outcome instrument for children with cerebral palsy. Subsequent randomized studies in spastic cerebral palsy have demonstrated some effects of TES with subjective reports or measures but were unable to show an effect using objective measures [2,9]. A recent review of electrical stimulation in cerebral palsy concluded the existing studies in the literature unfortunately had ''insufficient statistical power to provide conclusive evidence for or against these modalities'' [6].…”